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RSS FeedPosted by Michael Wonder on 19 Jun 2024
European Commission grants Sobi marketing authorisation for Altuvoct for treatment of haemophilia A
19 June 2024 - Sobi today announced the European Commission has granted marketing authorisation for Altuvoct's (efanesoctocog alfa), for the ...
Posted by Michael Wonder on 10 Jun 2024
European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK positive early-stage lung cance
10 June 2024 - Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK ...
Posted by Michael Wonder on 05 Jun 2024
Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix
4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 05 Jun 2024
Nidlegy marketing authorisation application submitted to EMA
4 June 2024 - First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully resectable melanoma in ...
Posted by Michael Wonder on 04 Jun 2024
CStone announces European Medicine Agency CHMP recommends approval of Cejemly (sugemalimab, anti-PD-L1) as first-line treatment for NSCLC
1 June 2024 - EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant ...
Posted by Michael Wonder on 03 Jun 2024
Biogen receives European Commission approval for Qalsody (tofersen), the first therapy to treat a rare, genetic form of ALS
30 May 2024 - Qalsody is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment ...
Posted by Michael Wonder on 03 Jun 2024
Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR mutated advanced lung cancer
3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 03 Jun 2024
Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer
31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...
Posted by Michael Wonder on 03 Jun 2024
Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo for the treatment of IgA nephropathy
30 May 2024 - Calliditas Therapeutics today announced that the CHMP of the EMA adopted a positive opinion recommending the ...
Posted by Michael Wonder on 03 Jun 2024
Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency
31 May 2024 - Zealand Pharma today announced that the CHMP of the EMA has issued a positive opinion recommending granting ...
Posted by Michael Wonder on 02 Jun 2024
Mirum Pharmaceuticals announces positive CHMP opinion for Livmarli (maralixibat) oral solution for the treatment of PFIC in patients three months of age and older
31 May 2024 - Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in ...
Posted by Michael Wonder on 02 Jun 2024
Takeda receives positive CHMP opinion for recombinant ADAMTS13 (rADAMTS13) in congenital thrombotic thrombocytopenic purpura
31 May 2024 - Positive opinion based on totality of evidence, including results from the first randomised, controlled, cpen-label, cross-over Phase ...
Posted by Michael Wonder on 02 Jun 2024
Dupixent recommended for EU approval by the CHMP to treat patients with COPD
31 May 2024 - Recommendation for adults with uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils based on data from ...
Posted by Michael Wonder on 02 Jun 2024
AbbVie receives positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderately to severely active ulcerative colitis
31 May 2024 - The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that ...
Posted by Michael Wonder on 01 Jun 2024
New gene therapy treatment for haemophilia B
31 May 2024 - The EMA has recommended granting a conditional marketing authorisation in the European Union for Durveqtix (fidanacogene ...